510(k) Report

FDA applicant

Sonometric Health, LLC

Bountiful, UT1 decision2003–20031 recall

FDA records 1 decision for Sonometric Health, LLC (Bountiful, UT) in 2003: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sonometric Health, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sonometric Health, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sonometric Health, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K030223SonocalcSonometric Health, LLC · 20036cite it

What has FDA decided for it lately?

  • K030223SonocalcSonometric Health, LLC · 20031 recall

The one decision as Sonometric Health, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K030223SonoCalc IMT 3.0, a windows based software used in conjunction with images from…Oct 26, 2005